What is a Preventive Action?

Preventive Action Definition

Preventive action is a system to eliminate any cause(s) that would create a potential hazard or undesirable situation. Changes can be made or implemented to address an issue, hazard, or weakness in a system. Preventive action also can include ways to improve an organization’s workflow or situation. A good preventive action process includes controls to make sure the preventive actions are in place and working and can differ from one company or organization to another.

What is a Preventive Action

FAQs

How do you write a preventive action plan?

A preventive action plan should include:

  • Description of the issue
  • Documented root cause analysis
  • Evaluation of the risk and opportunities of the preventive measure
  • Steps needed to prevent the issue
  • Implementation (i.e., allocation of resources, steps needed for execution, timeline, cost, etc.)
  • Follow-up measures (i.e., verification of effectiveness)

*Source: https://advisera.com/blog/2021/07/19/complete-guide-to-corrective-action-vs-preventive-action/

What is difference between corrective action and preventive action?

Corrective actions are a set of actions taken to rectify or change a process that causes errors or nonconforming events. Preventive actions are proactive measures that are taken to prevent nonconformities from occurring in the future.

*Source: http://www.differencebetween.net/business/difference-between-corrective-action-and-preventive-action/

Why are Capas important?

Corrective and preventive actions (CAPAs) help organizations improve their processes and prevent undesirable situations and nonconformities from occurring. CAPAs provide a systematic method for problem solving, ensure quality issues are resolved, reduce customer complaints, reduce scrap and rework costs, promote continuous improvement, and help organizations meet regulatory requirements.

*Source: https://www.propharmagroup.com/blog/why-capa-so-important-anyway-0/

What is an example of preventive action?

Examples of preventive actions include:

  • Implementing training programs for employees
  • Reviewing or auditing suppliers
  • Developing disaster recovery plans

*Source: https://i-sight.com/resources/building-an-effective-capa-plan-your-8-step-guide/

Best
Practice

Medical device companies must have a compliant Corrective Action Preventive Action (CAPA) process in place to comply with FDA 21 CFR 820.100. A collaborative quality system lets you check this FDA requirement “box” while facilitating corporate objectives. Learn the 5 essential elements of a CAPA system.